Pyng Medical Corp.

Pyng Medical Corp.

May 01, 2008 06:00 ET

Pyng Medical Receives US FDA and Health Canada Clearance for Expanded Use of FAST1™

Leading Sternal IO System Now Available For Both Adolescent and Adult Care Throughout the US, Canada and EU

VANCOUVER, BRITISH COLUMBIA--(Marketwire - May 1, 2008) - Pyng Medical Corp. (TSX VENTURE:PYT) today announced it has received regulatory clearance from both the US Food and Drug Administration (FDA) and Health Canada to market its FAST1™ Intraosseous (IO) Infusion System for use in adolescent populations, in addition to adults throughout the US and Canada, effective immediately. FAST1™ also cleared for adolescent and adult use in the European Union (EU) through its' CE Mark.

FAST1™ is the most rapid, reliable and safe alternative to conventional IV infusion providing lifesaving vascular access for fluid and drug resuscitation in shock and trauma victims.

"We've enjoyed considerable success commercializing FAST1™ for use on adult populations internationally, with six consecutive quarters of strong sustained growth in revenue from product sales and profitability. As a result of the expanded market clearance in the US, Canada and Europe, we now look forward to providing life-saving technology to assist a broader demographic population ranging from 12 years of age through adulthood," said David Christie, President and Chief Executive Officer. "FAST1™ is now the only single IO product cleared for use in both adolescents and adults increasing the size of our markets and providing greater access for young people in their teenage years to Pyng's award-winning emergency medical technology."

Pyng Medical received regulatory clearance from both the US FDA and Health Canada for expanded use of the FAST1™ through a parallel expedited review process, each completed in less than one month. As a result, the Company's lead clinical product will now be available for use on patients as young as 12 years of age throughout the US, Canada and EU.

About Pyng Medical Corp.

Pyng Medical Corp. is the developer and manufacturer of the proprietary, award-winning FAST1™ Intraosseous Infusion System. Pyng has received the exclusive 2008 Medical Device Company of the Year Award from LifeSciences British Columbia for its sustained achievements in commercializing the Company's proprietary FAST1™ Intraosseous Infusion System. The Company was also selected in the "2007 TSX Venture 50" Top 10 companies in Life Sciences based on solid financial metrics for the year ending December 31, 2006. With expanding markets in North America, Europe and Asia, the FAST1™ has worldwide application for use with hospitals, emergency medical services and military forces.

Safe Harbour Statement; Forward-Looking Statements: This release may contain forward-looking statements based on management's expectations, estimates and projections. All statements that address expectations or projections about the future, including statements about the Company's strategy for growth, product development, market position, expected expenditures and financial results are forward-looking statements. Some of the forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "projects", "indicates", and similar expressions. These statements are not guarantees of future performance and involve a number of risks, uncertainties and assumptions. Many factors, including those discussed more fully elsewhere in this release and in documents which may be filed with the British Columbia Securities Commission, the Alberta Securities Commission, the Ontario Securities Commission, the TSX Venture Exchange, as well as other USA Commissions, could cause results to differ materially from those stated. These factors include, but are not limited to changes in the laws, regulations, policies and economic conditions, including inflation, interest and foreign currency exchange rates, of countries in which the Company does business; competitive pressures; successful integration of structural changes, including restructuring plans, acquisitions, divestitures and alliances; cost of raw material, research and development of new products, including regulatory approval and market acceptance; and seasonality of sales in some products.

The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

Contact Information

  • Pyng Medical Corp.
    David Christie
    (604) 303-7964